FDA Human Study on Sealed Vasectomy Procedure: Early Results

M. Mutter, L. Jones, T. Hakky, M. Henry, W. Nighan, G. Henry

Surgery, Vasectomy, Bipolar Sealing, Infertility, Contraception

Introduction:

The Sealed Vasectomy Procedure (SVP) is a new bipolar radiofrequency sealing tool for transdermal and open vasectomy in hopes of making the procedure a faster, simpler, and safer office procedure. Testing has been successful in rabbits and canine with excellent wound healing, complete vas occlusion on histology, and no sperm in post procedural semen analysis. The animal study data was presented as a video submission and subsequently won the AUA 2022’s “Best Video” of the andrology / infertility / sexual dysfunction session. Further studies in larger animals were request by the FDA in the course of a pre-submission review. FDA-approval is needed prior to its application in humans.

Objective:

Evaluate the effectiveness of the SVP in sealing the vas deferens in Humans during a vasectomy procedure

Methods:

The FDA directed the study design. 8 human subjects undergoing open vasectomy. The SVP was used for sealing the Vas deferens once exposed. Wound healing, semen analysis and outcomes are to be evaluated.

Results:

8 / 8 human vasectomies have been done thus far. The SVP worked very well in sealing the vas deferens. Wound healing appears to be good. More follow up will be done.

Conclusions:

SVP is a potentially exciting novel vasectomy procedure that appears to provide good sealing of the vas deferens in the Human study trial. FDA-approval is still needed before use in humans.